Post Partum Hemorrhage
Conditions
Brief summary
IN THIS STUDY WOMEN UNDER GOING ELLSCS WOULD BE DIVIDED INTO TWO GROUPS , ONE GROUP WOULD BE GIVEN TRANEXAMIC ACID WHILE THE OTHER WOULD BE GETTING PLACEBO PROPHYLACTICALLY TO SEE THE EFFECT OF TRANEXAMIC ACID IN PREVENTING PPH. THIS IS A RANDOMIZED CONTROLLED TRIAL. THE SAMPLING TECHNIQUE WOULD BE NON-PROBABILITY TECHNIQUE RANDOMIZATION WOULD BE DONE VIA BALLOTING METHOD.
Interventions
DRUGTranexamic Acid (TXA)
I would like to see the effect of prophylactic tranexamic acid in women undergoing ELLSCS in preventing PPH in my setup.
DEVICEPlacebo
one group will get placebo
Sponsors
Patel Hospital, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women with singleton pregnancy and low risk for PPH admitted for ELLSCS
Exclusion criteria
Women with medical disorder or complex pregnancy. * Women with history of PPH. * Women with bleeding disorder. * Abnormal placentation (MAP, placenta previa) * Multiple pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| prophylactic tranexamic acid in prevention of post-partum haemorrhage in ELLSCS | 6 months from the time of approval from CPSP till the completion of data collection | In this study, the role of tranexamic acid is being observed in preventing PPH in women undergoing ELLSCS by dividing women into two groups and giving one group placebo while the other would receive tranexamic acid. Two boxes, A and B, each containing 52 vials of the same size and color; one would contain the drug, i.e: TXA 1000 mg in 10 ml , while the other would contain a placebo in 10 ml vial, provided by a company; these would be revealed at the end of the study. A jar containing 104 chits, 52 of which would have the letter A written on them and the other 52 would have the letter B, would be kept in GYNAE OT. Prior to ELLSCS, a chit would be selected from the jar, and the patient would be given the drug according to the chit. It's a triple-blinded study; the patient, doctor, surgeon, and data analyst all will be blinded. |
Countries
Pakistan
Contacts
Primary ContactNIMRA ABID
Outcome results
None listed